Current Cholangiocarcinoma Trials

Listed here are the clinical trials for those with cholangiocarcinoma (bile duct cancer) or gall bladder cancer, currently open and recruiting in the UK.

Current Cholangiocarcinoma Trials

Wherever possible links for further information have been included to follow up for more information and to check eligibility.  Each trial has specific eligibility criteria, so if you are interested in taking part in one, please discuss with those running the trial (contact details are given where possible) and/or your consultant.

Please note it is not appropriate for AMMF to give medical advice or recommendations, and all details provided are for information purposes only.


Molecular Profiling, Targeted Therapies and Immunotherapy

No two tumours are exactly the same. The genetic characteristics of a cancer will vary from one patient to the next, which means that even patients with the same type of cancer may respond differently to the same treatment.

Current scientific advances mean that cancer treatments are moving towards those more specifically targeting the tumour ‘drivers’, and ways to inhibit these drivers. Progress is beginning to be made in the understanding of cholangiocarcinoma, with studies being carried out to find target agents, and also genomic or molecular profiling, in the search for better and more effective treatments.

Several of the clinical trials listed here are looking at targeted therapies and will require molecular profiling to be carried out first to see if a patient has the particular mutation or fusion which the therapy will act on.

For more information on Molecular Profiling and Targeted Therapies

For more detailed information, plus a short animated film “Cholangiocarcinoma and the importance of molecular testing” and a booklet, “ Molecular testing in cholangiocarcinoma”, click here

For information on therapy approvals by NICE
(targeted therapies and immunotherapy)click here

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SAFIR ABC-10

SAFIR ABC-10 is a Phase 3, international (UK, France, Belgium) multicentre, randomised, trial to evaluate whether the introduction of molecular targeted therapy as maintenance treatment after 4 cycles of standard-of-care first-line systemic therapy* is better than the continuation of standard-of-care first-line systemic therapy in the treatment of patients with Advanced Biliary Cancer (ABC; cholangiocarcinoma; bile duct cancer). 

The trial is composed of two phases:

1 An initial screening phase to identify suitable patients

2 A randomised comparative trial

*Current standard-of-care first-line systemic therapy is durvalumab plus gemcitabine and cisplatin. For more information on this, see: https://ammf.org.uk/treatment-options/#chemotherapy

For a more detailed overview of the SAFIR ABC-10 trial, please click the Read More button

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DETERMINE

DETERMINE is the first UK national precision medicine trial in rare cancers*, testing a range of therapies specifically targeting key genetic changes in cancer cells.

A non-randomised trial, DETERMINE will explore whether treatments approved for use in some cancer types can target identifiable genetic alterations in other types. And provide new treatments options for those who might not have any left.

This could include those with a BRAF V600 mutation-positive cholangiocarcinoma, or with HER2 amplification or activating mutations.

For further details, please see the Read More page. 

* Rare is defined generally as incidence fewer than 6 cases in 100,000 patients, or common cancers with rare alterations

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Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. It is for people for whom previous treatment was not successful or no treatment exists.

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Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Patients With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

This is a Phase 1/2 study evaluating the safety, tolerability, and activity of the targeted therapy ivosidenib in combination with immunotherapy in patients with nonresectable or metastatic cholangiocarcinoma with an IDH1 mutant. 

Please note: For those with CCA who have an IDH1 mutation and who have already undergone one other treatment, NICE have approved the targeted therapy ivosidenib.  For more information on ivosidenib for CCA with an IDH1 mutation, and other CCA treatments, see: https://ammf.org.uk/treatment-options/

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An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer

This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab.

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FIGHT-302

FIGHT-302: Phase 3 Study of First-line Pemigatinib Versus Gemcitabine Plus Cisplatin for Cholangiocarcinoma With FGFR2 Fusions or Rearrangements.

This study will compare chemotherapy (CisGem) with an FGFR-inhibitor in FGFR-altered patients and will require prior analysis of a tumour biopsy to determine that there is the appropriate FGFR-alteration.

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HERIZON-BTC-01

Although this study is now closed to recruitment, Zanidatamab (also know as ZW25) is available for eligible CCA patients under an Expanded Access/Compassionate Use Program.

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The ABC-12 Study 

ABC-12: Exploring the microbiome in patients with advanced biliary tract cancer (including cholangiocarcinoma and gallbladder cancer) in a first-line study of those receiving durvalumab in combination with gemcitabine and cisplatin.

This research study is evaluating the microbiome of patients undergoing treatment. 

All patients will receive the immunotherapy durvalumab plus chemotherapies gemcitabine and cisplatin.

Durvalumab plus gemcitabine and cisplatin was approved by NICE in January 2024 as the first line standard of care for those with inoperable cholangiocarcinoma or gallbladder cancer.  For more details, click here

For a patient guide to the first line treatment durvalumab plus gem/cis, click here

Read More

Asp-PSC – a study for those with primary sclerosing cholangitis (PSC) 

Evaluating aspirin in reducing cancer and improving outcomes for those with primary sclerosing cholangitis.

If you are interested in finding out more about this study, please click the Read More button.

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Biliary Tract Cancer Virtual Tissue Bank – BTC VTB

Biliary tract cancers include cholangiocarcinoma (intrahepatic, perihilar, and extrahepatic), gallbladder cancer and ampullary cancer

The aim of the Biliary Tract Cancer Virtual Tissue Bank (BTC VTB) is to create a national tissue bank of human tissue samples (e.g. blood, tissue) from patients who had a biliary tract cancer and who have taken part in particular clinical trials. 

The samples will be stored in two locations in Manchester and London and the management of the samples will be run by UCL Cancer Trials Centre in London. 

Biliary tract cancers are quite rare with poor outcomes and it is often difficult to obtain large amounts of tissue, which makes this tissue bank extremely valuable.  Our aim is to make samples available for researchers so that more research can be done in biliary tract cancers which will, hopefully, help future patients. If we are better able to understand these cancers then the correct treatments can be used in clinical trials, which will then be used in clinic if successful.  

For more information: https://www.ctc.ucl.ac.uk/TrialDetails.aspx?Trial=125&


Trials in set up

For information on trials that are currently in set up, please click here


Current trials no longer recruiting

For information on trials that are no longer recruiting, but are still live, please click here


National Institute for Health Research

The NIHR (National Institute for Health Research) “Be Part of Research” website has details of all UK clinical trials. Visit: bepartofresearch.nihr.ac.uk and search for the name or number of the trial you are interested in.

Cancer Research UK also lists clinical trials for bile duct cancer (cholangiocarcinoma).  To see this, click here

For information on current treatments for cholangiocarcinoma, click here

May 2024